GLP-2 analogue
Teduglutide dose
Answer
FDA label for Gattex: The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. Trials with posted results tested 5 doses, most often 3 mg, 4 mg, 0.05 mg/kg.
Not dosing advice.
FDA LABEL
What the approved labels state
Gattex NDA203441 · label of 2025-09-05 Regulator
The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection.
IN TRIALS
Doses tested in 20 trials with posted results
| Dose in the arm title | Trials | People on it | Phases |
|---|---|---|---|
| 3 mg | 1 | 64 | 1 |
| 4 mg | 1 | 64 | 1 |
| 0.05 mg/kg | 2 | 61 | 3 |
| 0.1 mg/kg | 1 | 32 | 3 |
| 0.025 mg/kg | 1 | 24 | 3 |
Trial register Read from the titles of arms that received Teduglutide (n ≥ 20). An arm naming several doses counts under each; a schedule or escalation is on the trial record. All trials.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.